Prevention of type 2 diabetes in women with gestational diabetes in urban India - A feasibility study
Gestational diabetes mellitus (GDM) is a strong risk factor for developing future ‘chronic’ or type 2 diabetes. It is common among Indian women. Limited information about lifestyle programs to prevent or delay type 2 diabetes in women with gestational diabetes mellitus is available from other countries, but their applicability in India is unknown.
Aims
The overall aim of this project is to inform the design and conduct of a large-scale cluster randomised study to reliably evaluate the effectiveness of a lifestyle intervention for the prevention of type 2 diabetes in women with gestational diabetes in India.
Methods
Phase One
In two public urban Indian hospitals, 500 consecutively-identified women with GDM will have an oral glucose tolerance test administered six or more weeks following delivery. Proportions with normal glucose tolerance, abnormal glucose tolerance and established type 2 diabetes will be estimated.
Phase Two
Around 60 of these patients without type 2 diabetes will be invited to undergo a group lifestyle intervention, comprised of six two-hour sessions delivered over an eight month period. The intervention, based on a program currently being deployed in Australia, will be adapted for delivery in the Indian context by specifically-trained facilitators. Feasibility will be evaluated by measurement of attendance and completion, and qualitatively, through semi-structured interviews of patients and facilitators. Baseline and follow-up measurement of selected clinical variables will help inform sample size calculations for a subsequent controlled evaluation of the program’s effectiveness.